BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED

    MDR report key: 3071343 · Received April 22, 2013

    Report

    Report Number
    2210968-2013-04253
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE REVEALS A PIERCING THROUGH WHICH A GLASS SHARD PROTRUDED IN THE APPLICATOR BULB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND TOPICAL SKIN ADHESIVE WAS USED. WHEN DISPENSING THE PRODUCT A GLASS SHARD PENETRATED THE AMPOULE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172906 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE MPN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1